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BIOMET 3i Dental Abutments are intended for use as accessories to endosseous dental implant to support a prosthetic device in a partially or completely edentulous patient. A dental abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained to the abutment.

Restorative Components:

• . Temporary Healing Abutments are intended for use to shape and maintain the soft tissue opening during healing.
• Castable restorative components are intended for use as accessories to endosseous dental . implants to aid in the fabrication of dental prosthetics.
• Screw componenets are intended for use as accessories to endosseous dental implants for . retention of screw retained abutments to the dental implant.

The BIOMET 3i dental pre-formed and castable abutments and other restorative components consists of a variety of abutments, posts, cylinders and screws which are utilized to support the single and multiple tooth prostheses for either screw retained or cement retained restoration. These devices include appropriate features and dimensions to mate with BIOMET 3i dental implants cleared by K063341 and K063286 with either internal connections. The abutments may be used for single and multiple teeth.

This 510(k) submission (K072642) for BIOMET 3i Dental Abutments and Restorative Components focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be extracted from the provided text for this device. The submission explicitly states:

"The modified BIOMET 3i dental pre-formed and castable abutments and other restorative components are equivalent to the predicate BIOMET 3i dental abutments and restorative components having the same intended uses, indications, technological characteristics, and principles of operation as the predicate device(s). The minor technological differences between the modified components and their predicate devices raise no new issues of safety or effectiveness. Thus, the modified dental abutments are substantially equivalent to their predicate devices."

This indicates that the manufacturer is demonstrating that their device is sufficiently similar to existing legally marketed devices, and thus does not require new primary performance data to prove safety and effectiveness.

Summary of what cannot be provided from this document:

1. A table of acceptance criteria and the reported device performance: Not applicable, as no new performance study with specific acceptance criteria and metrics is presented.
2. Sample size used for the test set and the data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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